Hilden, Germany, and Germantown, Maryland, November 29, 2018 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of two novel products to deliver actionable insights on a wide range of blood cancers: a new workflow for the QIAGEN Clinical Insight (QCI) Interpret bioinformatics solution for hematological malignancies, and the new QIAact Myeloid DNA UMI Panel for use in myeloid neoplasm research as a Sample to Insight workflow on QIAGEN’s GeneReader NGS System.
QIAGEN is a leader in molecular testing for blood cancers with its ipsogen portfolio of molecular assays, most of which are CE-marked for in vitro diagnostic use. In addition, QIAGEN supplies a very broad portfolio of solutions for research into blood cancers. The company also has a broad intellectual property estate in genes related to blood cancers. These new solutions represent very exciting extensions of this leading blood cancer testing franchise, adding to the complete set of oncology solutions available from QIAGEN.
QIAGEN will highlight these additions to its portfolio at the American Society of Hematology (ASH) 2018 Annual Meeting and Exposition from December 1-4, 2018, in San Diego. QIAGEN solutions are featured in a number of research studies being presented at ASH 2018.
“We are pleased to introduce to the scientific and clinical leaders gathered at ASH 2018 QIAGEN’s newest Sample to Insight solutions covering a full range of hematological malignancies. Our QCI Interpret workflow is a very powerful bioinformatics solution for making treatment decisions based on the world’s deepest knowledge base of evidence on genomic variants and disease,” said Thierry Bernard, QIAGEN’s Sr Vice President and Head of Molecular Diagnostics. “We are also launching the QIAact Myeloid DNA UMI Panel, expanding the content menu of our GeneReader NGS System to offer end-to-end, automated workflows to provide actionable insights to cancer researchers on the many genomic variations in blood cancers. These new product launches are further confirmation of our leading position in providing laboratories with solutions that will help improve patient outcomes, and above all achieve our vision of helping to make improvements in life possible.”
QIAact Myeloid panel covers 25 relevant genes
The new QIAact Myeloid DNA UMI Panel for the GeneReader NGS System provides an integrated Sample to Insight workflow targeting the genes and variants of most relevance to onco-hematology research. Developed in collaboration with internationally known onco-hematology experts, the QIAact Myeloid panel is integrated with comprehensive bioinformatics for analysis and interpretation. The panel will be available for research use only in December 2018.
The QIAact Myeloid panel covers 25 highly relevant genes and their variants, including single nucleotide variants (SNVs) and insertions/deletions (InDels) of known significance to clonal myeloid malignancy. The genes targets have been thoroughly selected for their occurrence and relevance in myeloid malignancies stated by international references and organizations including the 2016 WHO classification categories, National Comprehensive Cancer Network (NCCN), European LeukemiaNet (ELN), MPN&MPNr-EuroNet and the European Society for Medical Oncology (ESMO). Among the genes targeted are JAK2, CALR, IDH1/2, FLT3, KIT, SRSF2, TP53 and others that are highly relevant in cancer. For more information on the QIAact Myeloid DNA UMI Panel, please visit http://www.qiagen.com
QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR, such as a targeted research panel for use on any major next-generation sequencing platform, the Human Myeloid Neoplasms QIASeq DNA Panel, enabling analysis of 141 genes most commonly involved in myeloid neoplasm development and progression, or the ipsogen JAK2 RGQ PCR Kit for the detection of the JAK2 V617F/G1849T mutation implicated in certain blood cancers.
QCI Interpret delivers hematology insights
The new workflow for QCI Interpret was designed to consider the heterogeneous nature of myeloid malignancies and provides actionable information for the sub-classification and prognostic assessment of hematological malignancies, including leukemia, Non-Hodgkin lymphoma, Hodgkin lymphoma and multiple myeloma. QCI Interpret is a web-based clinical decision support platform that draws upon the industry-leading QIAGEN Knowledge Base to evaluate genomic variants in the context of published biomedical literature, professional association guidelines (AMP/ASCO/CAP and ACMG/AMP), publicly and privately available databases, drug labels and clinical trials.
One of the major challenges in managing hematological cancers is keeping pace with the rapid proliferation of scientific publications. As growing use of next-generation sequencing (NGS) increases the rate at which genetic mutations are characterized for clinical relevancy, more and more studies highlight alterations in the context of a disease, prognostic outcome or therapeutic response. QCI Interpret addresses the challenge of collecting, analyzing and using data to guide treatment decisions. The software replaces time-consuming manual research to determine an alteration’s prognostic or diagnostic actionability, ranking the data according to the highest level of evidence based on actionability tiers from the 2017 AMP/ASCO/CAP guidelines. In addition, QCI Interpret automatically provides somatic frequency data on hematological cancers from the World Health Organization (WHO) and combines the WHO diagnostic information on genetic alterations with NCCN guidelines, QCI Interpret enables a complete assessment of actionability.
With a full hematology-oncology workflow, QCI Interpret now provides all relevant prognostic and diagnostic information on blood cancers, creating reports for decision-making with greater confidence and efficiency. For more information, please visit https://www.qiagenbioinformatics.com/qiagen-clinical-insight-interpret/
QIAGEN’s presence at ASH 2018
At this year’s ASH annual meeting, QIAGEN’s products and services are featured in more than 19 abstracts presented at the Conference. QIAGEN will meet with attendees and demonstrate its novel Sample to Insight solutions for hematological cancers and other applications in Booth #1557.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2018, QIAGEN employed approximately 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected sales, adjusted net sales and adjusted diluted earnings per share results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics); variability of operating results and allocations between customer classes; the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).